A Comparison of Hemorrhagic and Ischemic Strokes Among Blacks and Whites (GCNKSS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Brett Kissela, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00642213
First received: March 19, 2008
Last updated: May 27, 2015
Last verified: May 2015

March 19, 2008
May 27, 2015
July 1993
April 2020   (final data collection date for primary outcome measure)
mRS [ Time Frame: 30 days ] [ Designated as safety issue: No ]
modified Rankin Scale
Not Provided
Complete list of historical versions of study NCT00642213 on ClinicalTrials.gov Archive Site
mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Comparison of Hemorrhagic and Ischemic Strokes Among Blacks and Whites
A Comparison of Hemorrhagic and Ischemic Strokes Among Blacks and Whites: A Population-Based Study in Cincinnati, Ohio

Our primary goal is to study temporal trends in the incidence rate, causes, treatment, and outcome of stroke among a large biracial metropolitan population of 1,349,351, of whom 215,611 (15%) are black (2000 Census). Such data are critical for the planning, intervention, and evaluation of public health efforts to decrease the mortality and morbidity due to stroke in the United States.

We have completed this goal for 1993-94, 1999, 2005, and 2010. We ware in the process of collecting this data for 2015. In the 2015 study period we will also be ascertaining 3 year recurrence rates for all incident stroke events.

For calendar years 1993-94, 1999, 2005, 2010, and 2015 we will identify every hospitalized or autopsied stroke and transient ischemic attack (TIA) at all regional hospitals in our region. We will also estimate the number of non-hospitalized strokes and TIAs by screening for potential cases at more than 100 outpatient sites throughout five counties in Greater Cincinnati/Northern Kentucky. We plan to identify and abstract detailed information from the medical record for every potential case. These results will be compared with data from all stroke patients identified by similar methodology in all study periods.

In addition, we have interviewed 1500 ischemic stroke patients and/or their families in the study periods 1999-2010 to obtain detailed information including demographic information, functional outcome and quality of life, access to and type of rehabilitation therapy, social support, caregiver availability and health status, access to post-hospital care, health insurance status, current health status, medications, prior risk factors, and knowledge about stroke signs and symptoms. We also obtained genetic material via a blood sample for most of this cohort.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

We have collected blood and/or buccal samples from an interviewed cohort during years 1999,2005, and 2010.

Non-Probability Sample

Prospective cohort:Ischemic stroke patient in 1999/2005/2010 that resides in the GCNK area.

Retrospective cohorts: All stroke and TIA events occurring during the following study periods: 1993-94, 1999, 2005, 2010, and 2015. This group is ALL stroke patients of any age that resides in our 5 county region.

  • Ischemic Stroke
  • TIA
  • Hemorrhage
Not Provided
  • 1
    We prospectively collected 450(1999), 502(2005), and 512(2010) ischemic stroke patients who agreed to participate and also most provided a sample for DNA. The cohort data consists of a baseline interview, medical record abstraction and various timeframes of followup interviews from 3m to 3yrs.
  • 2
    The second part of the study is a retrospective medical record review of all potential ischemic strokes, TIAs, and Hemorrhagic strokes in our 5 county region that occurred in all study years.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1200
April 2020
April 2020   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ischemic stroke
  • occurred in 1999/2005/2010
  • >18 years old
  • resides in 5 county region

Exclusion Criteria:

  • <18 years old
  • resides outside 5 county region
  • inability to consent or have legal proxy consent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00642213
NS30678, NIH GRANT:NS30678
No
Brett Kissela, University of Cincinnati
University of Cincinnati
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Brett M Kissela, MD University of Cincinnati
University of Cincinnati
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP